Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT02464995
Eligibility Criteria:
Inclusion criteria:
* Age 18-65 years
* Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5
* Four or more bursts of systemic corticosteroids \>3 days each in the previous year
* Willingness and ability to give written informed consent
Exclusion criteria:
* Current smoker and former smoker \> 10 pack years total smoking history
* Participation in another clinical trial within the prior 4 months
* Omalizumab therapy within the prior 4 months
* Allergic bronchopulmonary aspergillosis
* Patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (\> 60 mg equivalent prednisolone) more than one month in the previous year
* Post-bronchodilator FEV1 of less than 30%
* Past diagnosis of COPD and chronic respiratory insufficiency
* Known coagulopathy or platelet dysfunction
* Use of anticoagulants
* Use of an internal or external pacemaker or internal cardiac defibrillator
* Contraindication to perform bronchoscopy
* Contraindication to perform general anesthesia
* Significant cardiovascular disease
* Current or recent respiratory tract infection resolved less than 4 weeks
* Known cancer or cancer history less than 12 months
* Pregnancy and nursing mother
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02464995
Study Brief:
Protocol Section:
NCT02464995